Measurement of Endothelial Function and Cardiac Output: New Methods

Completed

• Conditions: Hypertension; Hypertension, Pulmonary; Heart Failure; Diabetic Nephropathies
• Interventions: Device: Endo-PAT; Device: NICOM

• Registration Number: NCT02299960
• Lead Sponsor: Charite University, Berlin, Germany

Brief Summary

The main purpose of this study is to analyse test-retest-reliability of functional quantification of endothelial dysfunction through puls-amplitude-tonometry in patients with heart failure with preserved/reduced ejection fraction, pulmonary hypertension, arterial hypertension and diabetic nephropathy. In the same group, test-retest-reliability of circulating endothelial cells as well as test-retest reliability of non invasive cardiac output Monitoring will be observed and analysed.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-08
• Study First Submitted: 2014-11-20
• Study First Submitted QC: 2014-11-20
• Study First Posted: 2014-11-24
• Primary Completion: 2015-09
• Study Completion: 2015-10
• Status Verified: 2016-06
• Last Update Submitted: 2016-06-09
• Last Update Posted: 2016-06-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 101

Inclusion Criteria

• Clinically stable for the last 4 weeks (not for HFrEF: 7 days)
• Signed consent form

HFpEF:

• Baseline-Echocardiography:
• hospitalization <= 12 months with diagnosis heart failure and E/E' > 8 or E' < 8 cm/s or
• BNP >= 100pg/ml or NT-proBNP >= 300pg/ml in the last 6 months or
• LAVI > 28 ml/m² and E/E' > 8 or E' < 8cm/s or PAPsys > 40mmHg and E/E' > 8 or E' < 8 cm/s
• Possibility to take part in cardiac stress test
• Heart failure NYHA I-III
• Sinus rhythm
• Max. O2-uptake on exertion < 20ml/kgBW/min

HFrEF

• HFrEF due to ischemic or non-ischemic reasons
• NYHA I-III
• Individually optimized and stable pharmacological therapy (including beta-blocker, ACE-Inhibitor, AT1-antagonist, aldosterone-antagonist)
• EF <=45%, Simpson Biplan PH
• NICE-Classification 2013 I/II
• PAH >= 25 mmHg
• Precapillary PAH: Wedge-pressure <= 15 mmHg, CO normal or low
• Postcapillary PAH: Wedge-pressure >= 15 mmHg, CO normal or low

Diabetic nephropathy:

• Diabetes mellitus Type 2 with oral or Insulin therapy and one or more of the following:
• Diabetic nephropathy has been diagnosed before (anamnesis)
• Macroalbuminuria: Urine Albumine/Creatinine-ratio > 300mg/g Creatinine (>34mg/mmol) in 2 out of 3 tests of Urine in the morning and GFR <90ml/min/1.73m² (CKD-EPI)
• Microalbuminuria: 30-300mg/g Creatinine (>=3.4 mg/mmol but <34mg/mmol) tested as above and GFR < 90 ml/min/1.73m² and diabetic retinopathy

AH:

• Hypertension diagnosed at least 6 months except structural heart disease: EF > 55% and no sign of HFpEF
• No symptoms of coronary heart disease
• Possibility to take part in cardiac stress test
• Stable pharmacologic therapy of Hypertension for at least 4 weeks
• Systolic blood pressure <140 mmHG during Screening

Exclusion Criteria

• Patient incapable of contracting
• Angina pectoris > CCS II
• Coronary Intervention in the last 4 weeks or scheduled Intervention/Bypass
• Myocardial infarction in the last 3 months
• Stroke in the last 3 months
• Valvular heart disease > II°
• Cardiomyopathy due to Infiltrate/hypertrophic obstruction (e.g. HOCM, Amyloidosis)
• Congenital complex heart disease
• Active myocarditis
• Significant lung disease
• Significant Cardiac dysrhythmia
• Scheduled changes in medication during time of study
• (Scheduled) heart transplant
• Cardiac resynchronisation therapy over the last three months
• ICD/Pacemaker-implant in the last 4 weeks
• Uncontrolled Hyper/Hypotension (>180mmHg, <95mmHg)
• Patient taking part in Rehabilitation program
• Diagnosed Malignant disease or disease with life expectancy < 1 year
• Anemia with Hb<10mg/dl
• Untreated significant thyroid disease

HFpEF, Hypertension and PH:

• Patient incapable of cardiac stress test (e.g. because of orthopedic Problems)
• Significant changes in cardiovascular Status over the two weeks of study
• Instable cardiopulmonary Status over the last four weeks

HFrEF:

• I.v. Treatment with inotropic drug or diuretic in the last 7 days before Screening
• Myocardial infarction in the last 4 weeks

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
HFpEF	NICOM	patients with heart failure with preserved ejection fraction
HFrEF	Endo-PAT	patients with heart failure with reduced ejection fraction
AH	NICOM	patients with hypertension
Nephropathy	Endo-PAT	patients with diabetic nephropathy
AH	Endo-PAT	patients with hypertension
HFpEF	Endo-PAT	patients with heart failure with preserved ejection fraction

Primary Outcome Measures

Name	Time	Method
Test-retest-reliability EndoPAT	2 weeks

Secondary Outcome Measures

Name	Time	Method
Correlation: Cardiac Output on exertion and cardiopulmonary exercise test and 6 Minute Walking test	2 weeks
Correlation cardiac Output on exertion and echocardiography in HFpEF	2 weeks
Test-retest-reliability NICOM	2 weeks
Variability of biomarkers of myocardiac remodelling and of cardiorenal syndrome	2 weeks
Clinical feasibility of circulating endothelial cells and EndoPAT	2 weeks
Test-retest-reliability circulating endothelial cells	2 weeks
Correlation: circulating endothelial cells and EndoPAT and endothelial function	2 weeks	will include the molecular diagnostic of circulating endothelial cells

Trial Locations

Locations (1)

Charite Universitaetsmedizin; 🇩🇪 Berlin, Germany